EXACT Therapeutics’ clinical trials
The ENACT study
EXACT is preparing to start a Phase 2 study where the safety and efficacy of ACT will be investigated in combination with standard of care as 1st line treatment in patients with borderline resectable or unresectable locally advanced pancreatic cancer – the ENACT study.
The ACTIVATE study
Safety and anticancer activity of ACT® is currently being evaluated in a Phase I, multi-centre, clinical trial (NCT04021277) in patients with liver metastases secondary to colorectal cancer – the ACTIVATE study.
ACTIVATE is led by Professor Udai Banerji from the Institute of Cancer Research, The Royal Marsden Hospital, UK. Other principal investigators are Professor Ruth Plummer (Freeman Hospital, Newcastle), Dr. Bristi Basu (Cancer Research UK; University of Cambridge), and Professor Geir Olav Hjortland (Oslo University Hospital).
In the study, we use an innovative approach to assess within-patient effect of the combination of ACT with chemotherapy against chemotherapy alone by insonating one cancer lesion in the liver and comparing change in tumour size and volume with tumour lesions that have not been insonated.
Results of the dose escalation part showed that the ACT treatment is safe and had greater anticancer activity than chemotherapy alone.
8 hard-to-treat patients enrolled, with a median of 5 prior lines of therapies (range 3-7)
Up to 4 cycles of ACT (3x IV bolus of PS101 + ultrasound) + FOLFOX (5-fluorouracil [5FU], leucovorin, oxaliplatin) or FOLFIRI (5-FU, leucovorin, irinotecan)
6 evaluable for dose limiting toxicity and tumour response
Assessment by central reviewer, blinded to which lesion was insonated
No adverse events considered by the investigator related to ACT
